Contracts & Fiscal Management

Contracts & Fiscal Management addresses the contract negotiation for industry trials and budget setup on study start-up for Fred Hutch.During the life of the study, activities include invoicing and booking of revenue, as well as the renegotiation of contracts, when necessary.

Monitoring

CRS conducts monitoring according to the NCI-approved Institutional Data Safety and Monitoring Plan. All clinical research studies that are not monitored by another entity will be monitored by Clinical Research Support. The frequency and the scope of the monitoring are determined by the risk level of the study. All studies that support an IND held by a Consortium investigator, are Phase I studies, or meet the NIH definition of high risk are monitored twice per year. All other studies are monitored annually.

Protocol Review Coordination

Protocol Review Coordinators (PRCs) act as a liaison between the study team and the Institutional Review Board by advising study teams regarding the preparation and submission of new studies, annual renewals, and study modifications.Their primary expertise is navigating the review system and ensuring appropriate committee reviews.

Protocol Review Meeting Coordination

The meeting coordination team in CRS manages a range of meetings that support clinical research studies and initiatves. The focus is to arrange, conduct and record meetings with a particular focus on the Protocol Review & Monitoring system mandated by the Center's status as a Comprehensive Cancer Center.

Quality Management

The Quality Management program exists to increase compliance with GCP, establish standards for study coordination, and billing compliance.It serves as a link between the existing monitoring and training programs and will provide an evidence-based approach to efficient use of both resources.

Regulatory Affairs

Regulatory Affairs provides services related to clinical research and manufacturing conducted in the Cancer Consortium that is regulated by the FDA.

Manufacturing: Consulting with manufacturing facilities at both Hutch and SCCA, Regulatory Affairs provides guidance and technical writing support for manufacturing processes, quality systems, and submissions to the FDA.

Clinical Research: Regulatory Affairs provides advice, reviews of documentation or technical writing support for clinical research studies that are submitting to the FDA.

Research Management Data

Research Management Data gathers and reports up-to-date information on a real-time basis related to the research management of the Consortium. This is provided not only to support the management of the daily CRS operations, but also many departments and programs within the Cancer Consortium as well as reporting to our funding agencies. There are several databases utilized in Clinical Research Support:

PIRO: Consortium protocol information as well as information required for the Clinical Research Support operations

Training

Clinical Research Support manages the Clinical Research Coordinator Training which brings together both CRS and other Consortium Member resources for a multi-day training event twice per year.

CRS also helps to manage Consortium Study Coordinator (CSC) meetings. These clinical and research-oriented agendas, organized for research coordinators from the Fred Hutchinson Cancer Research Center, SCCA, and UW, are based on topics of timely import. Items of ongoing interest are brought back on a regular basis